The background description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art.
Many people work in high-risk fields where traumatic injuries resulting in severe bleeding, burns, or tissue damage are likely to occur. Such people include athletes, stuntmen, military servicemen, medical professionals, police officers, firefighters, construction workers, iron and steel workers, and veterinary service professionals. Even those who do not work in high-risk fields sporadically find themselves in situations where it is necessary to clean a wound, stop a bleed, or manage pain, although further treatment at a clinic or hospital is often required or recommended.
Existing options for non-medical professionals temporarily or otherwise treating minor injuries include Dermoplast™ pain relieving and antibacterial sprays, Bactine™ pain relieving cleansing spray, and Medique™ topical wound care line of products. However, such options are formulated for external/topical use, and do not appear to be appropriate for use to stop a bleed where there is a severe injury, such as a stab wound, laceration, amputation, or gun shot wound.
For more serious injuries, non-medical professionals often attempt to apply a tourniquet or a constant, direct pressure with layers of gauze or cloth. They may also attempt to clean the wound with alcohol or peroxide, apply an antibiotic ointment, or apply bandages to the skin outside the wound as a placeholder until the patient can be seen by a medical professional.
Unfortunately, existing emergency treatment options suffer from various disadvantages, such as the inability to effectively stop the bleed, inability to at least temporarily relieve pain, and inability to seal a wound from infection or further bleeding without a third party applying a constant, direct pressure on the injury. Additionally, many non-medical professionals are not aware of the steps necessary to properly treat or manage a wound, which can be numerous and risky. Moreover, and especially where gauze or other materials were used to attempt to seal a wound, removal often adds further traumatic injury, especially where the material has been in contact with the wound for longer periods of time (e.g., several hours or days).
Certain sealing compositions are known in the art, although they are applicable and used in very different contexts. For example, US 2008/0226577 to L'Alloret et al. and U.S. Pat. No. 8,691,202 to Yu et al. teach cosmetic kits for topical use, wherein separately packaged compositions form a thin film to hide wrinkles and other skin imperfections. However, the compositions of L'Alloret and Yu are not suitable for treatment of a wound or placement within a body cavity, and there does not appear to be any indication that such compositions would even form a film in the presence of blood or tissue. These and all other extrinsic references are incorporated herein by reference in their entirety. Where a definition or use of a term in an incorporated reference is inconsistent or contrary to the definition of that term provided herein, the definition of that term provided herein applies and the definition of that term in the reference does not apply.
As another example, LeGoo™, a poloxamer gel with reverse thermosensitive properties, is a biopolymer gel that allows surgeons to temporarily stop blood flow in a vessel during surgery without the use of a clamp or other conventional occlusion device (see e.g., Ann Thorac Surg. 2011 December; 92(6):2235-9). LeGoo is a liquid gel at colder temperature, and forms a plug when injected into a blood vessel. The plug dissolves via cooling or spontaneously after only several minutes, and cannot subsequently reform. LeGoo is not intended to be removed as a solid, and is only marketed for temporary endovascular occlusion of blood vessels up to 4 mm in diameter—not treatment or management of open wounds (e.g., wounds involving a break in skin, typically accompanied with bleeding). While LeGoo undergoes a temperature-induced phase change, there is no alteration in the product's chemical composition, and the material does not cure in situ. Consequently, LeGoo is not suitable for treatment of traumatic injury and is also not amenable for use over extended periods of time (e.g., more than 15-30 minutes, or hours). Furthermore, the FDA limits the sale of LeGoo to (or on the order of) physicians. Therefore, such gel would not be suitable for use by a non-medical professional.
Still other hemostatic compositions are known that are based on zeolite (e.g., QuikClot, Z-MEDICA, LLC, 4 Fairfield Blvd., Wallingford, Conn. USA 06492), collagen (Surgicel, Ethicon, US), or starch (TraumaDEX; Medafor, Inc., Minneapolis, Minn. 55430). While zeolite based hemostatic agents are often rapid in action, extreme caution must be taken as severe burns may develop due to exothermic reaction o the zeolite. Moreover, zeolites do not stabilize a would and motion of the injured can trigger reopening of the wound. Similarly, collagen and starch based compositions fail to physically stabilize a wound and are typically not suitable for more serious injuries such as lacerations, stab- or gunshot wounds, or amputations. Moreover, most of these compositions require complete removal prior to further treatment of the injury, which typically retraumatizes a patient.
Thus, while numerous compounds and compositions for wound treatment are known in the art, there is still a need for improved kits, compositions, and methods that will rapidly stop blood loss, even in large injuries, that will stabilize a trauma site, and that is easily removable from the site without retraumatizing a patient. In addition, there is also a need for wound treatments that can remain in place for an extended period, and that can be readily removed by a medical professional without re-injury of the patient.